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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02368834
Other study ID # 2011-4024-04-01
Secondary ID
Status Completed
Phase N/A
First received February 12, 2015
Last updated April 27, 2015
Start date August 2014

Study information

Verified date April 2015
Source Peking University
Contact n/a
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology Commission
Study type Interventional

Clinical Trial Summary

This study designed and evaluated a psychoeducation program for parents of ADHD children in terms of improving medication adherence and clinical benefits.


Description:

ADHD is the most common behavioral disorder with poor outcomes. Medication is the most important treatment for ADHD. The adherence to the medication is extremely low. This study aims to investigate the the effect of a psychoeducation program for parents of ADHD children. The investigators intent to recruit 80 ADHD families. They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in a psychoeducation program, which includes a presentation from a specialist in ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end of the 2nd and the 4th weeks. The control group only receives general consultation. The knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence, clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the 1st and 3rd months after intervention.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- parents of ADHD children diagnosed with ADHD

- 6 - 16 years old;

- first referral to the hospital;

- candidate for medication according to both the doctor and the family

Exclusion Criteria:

- inappropriate for medication;

- being illiterate of the parent or the primary caregiver;

- unable to be followed-up.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • ADHD
  • Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
psychoeducation
The intervention included a presentation by a psychiatrist, with parent manual provided, and then two group sessions at the 2nd and 4th weeks to address further concerns of the parents

Locations

Country Name City State
China Peking University Sixth Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medication adherence rate 3 months No
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